The eMESH 1 Feasibility Study
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - 85 |
| Updated: | 10/14/2017 |
| Start Date: | August 2012 |
| End Date: | June 2020 |
| Contact: | Rebecca Wetterling |
| Email: | clinical@kipsbaymedical.com |
| Phone: | 763-235-3540 |
A Multi-center, International Study of External Saphenous Vein Support Using eSVS® Mesh in CABG Surgery: The eMESH I Study
Multi-center, dual cohort (randomized and single vessel) study designed to demonstrate
feasibility, initial safety and performance of the Kips Bay Medical, Inc. eSVS® Mesh as an
external vein support device for use over saphenous vein grafts during coronary artery bypass
surgery. In the Randomized Cohort, each study subject will receive a SVG without Mesh
(control) and a SVG with the eSVS Mesh (treatment). In the Single Vessel Cohort, each study
subject will receive one SVG with the eSVS Mesh.
feasibility, initial safety and performance of the Kips Bay Medical, Inc. eSVS® Mesh as an
external vein support device for use over saphenous vein grafts during coronary artery bypass
surgery. In the Randomized Cohort, each study subject will receive a SVG without Mesh
(control) and a SVG with the eSVS Mesh (treatment). In the Single Vessel Cohort, each study
subject will receive one SVG with the eSVS Mesh.
Inclusion Criteria:
- Randomized Cohort: Requires CABG surgery with a SVG to the right coronary artery (RCA)
system AND the left circumflex artery (LCX) system with a ≥ 70% stenosis in each of
the two systems.
- Single Vessel Cohort: Requires CABG surgery with a SVG to the RCA system or the LCX
system with a > 70% stenosis in the system.
- Medial sternotomy with cardiopulmonary bypass (CPB) during surgery.
- Both saphenous vein graft length are adequate for planned intervention, vein outer
diameter is between 3.6 mm and 7.0 mm and double wall thickness less than 1.4 mm.
- Agreement to post-procedure follow-up contact and testing (including follow-up
coronary angiogram).
Exclusion Criteria:
- Concomitant non-CABG cardiac procedure.
- Prior cardiac surgery (does not include percutaneous procedures).
- Cerebrovascular or transient ischemia attack within 30 days of the CABG procedure.
- Age > 85 years.
- Left ventricular ejection fraction ≤ 35%.
- Creatinine > 133 μmol/L (1.5 mg/dL) prior to CABG procedure or on chronic dialysis.
- STEMI within 7 days or total CK > 2 times the upper limit of normal prior to the CABG
procedure.
- Both enrolled grafts will feed non-viable myocardial territory.
- Diffuse atherosclerotic disease (> 70%) distal to either of the enrolled target
coronary arteries.
- Randomized Cohort: By visual estimate, the target coronary artery diameter of both the
right coronary system and left circumflex system must be within 1.5mm of each other.
- Planned endarterectomy of the target coronary artery.
We found this trial at
6
sites
223 N Van Dien Ave
Ridgewood, New Jersey 07450
Ridgewood, New Jersey 07450
(201) 447-8000
Principal Investigator: Juan Grau, MD
Phone: 201-447-8000
The Valley Hospital The Valley Hospital is a fully accredited, acute care, not-for-profit hospital serving...
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550 Peachtree St NE
Atlanta, Georgia 30308
Atlanta, Georgia 30308
(404) 686-4411
Principal Investigator: Omar Lattouf, MD
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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1 Na Bojišti
Prague, 120 00
Prague, 120 00
Principal Investigator: Jaroslav Lindner, MD
Phone: +420 224 962 709
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